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NCT01605903 · ClinicalTrials.gov registry record · Phase 2
Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy
A Phase 2 study, sponsored by Massachusetts Eye and Ear Infirmary.
- Completed
- Registry status
- Phase 2
- Development phase
- 741
- Enrollment target
NCT01605903: Completed Phase 2 study, sponsored by Massachusetts Eye and Ear Infirmary.
NCT01605903 is a Phase 2 study that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 741 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (457% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01605903, a Phase 2 study, has completed, sponsored by Massachusetts Eye and Ear Infirmary.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 741 participants
- Enrollment target
Study Summary
Tonsillectomy (the surgical removal of the tonsils) is a commonly performed surgery in children. One risk of tonsillectomy is postoperative bleeding, and this can be more dangerous in children because their blood volume is lower than adults. Ibuprofen, a nonsteroidal anti-inflammatory medication (NSAID), is an effective pain medication. Recent guidelines, published by the American Academy of Otolaryngology, advocated use of ibuprofen after tonsillectomy. However, NSAIDs are associated with altered platelet function and a theoretical increased risk of bleeding after surgery. The investigators would like to explore the effect that ibuprofen has on postoperative bleeding, as well as validate previous studies demonstrating it is an effective pain medication after tonsillectomy.
Primary Outcome
Postoperative hemorrhage is defined as any history of bleeding occurring within the 14 day postoperative period. Hemorrhage will be stratified into 3 levels of severity. Level 1: includes children with a history of postoperative bleeding evaluated and/or treated by a physician in the emergency room, inpatient unit or operating room; Level 2: children requiring inpatient admission for postoperative bleeding regardless of the need for operative intervention; Level 3: children requiring inpatient a
Interventions
- DRUG Acetaminophen
- DRUG Ibuprofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 741 participants |
| Start Date | 2012-05-03 |
| Est. Completion | 2017-02-15 |
| Phase | Phase 2 |
What the finished NCT01605903 record still lists
NCT01605903 is an interventional study that assigns participants to a tested intervention. The registered 741 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (457% higher).
The record links to 0 conditions, and to 2 interventions - of which Acetaminophen is the first listed.
NCT01605903 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01605903 about?
NCT01605903 is a clinical study titled "Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy". Tonsillectomy (the surgical removal of the tonsils) is a commonly performed surgery in children. One risk of tonsillectomy is postoperative bleeding, and this can be more dangerous in children because their blood volume is lower than adults. Ibuprofen, a nonsteroidal anti-inflammatory medication (NS...
What is the current status of trial NCT01605903?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 741 participants. The study started on 2012-05-03. Estimated completion is 2017-02-15.
What interventions are being tested in trial NCT01605903?
The interventions under investigation include: Acetaminophen (DRUG), Ibuprofen (DRUG).
Who is sponsoring clinical trial NCT01605903?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01605903's enrollment target sits among peer trials
741 44th of 2000 higher than 1,957 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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